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OpenTrials
Completed

NCT Number: NCT00259753

Safety and Efficacy Study of Small Interfering Ribonucleic Acid (RNA) Molecule (Cand5) to Treat Wet Age-Related Macular Degeneration

The objective of this study is to evaluate the safety and preliminary efficacy of three doses of Cand5. Cand5, a small interfering RNA molecule that selectively silences the mRNA encoding for VEGF.

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Key information

Conditions

Macular Degeneration Eye Diseases Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Acuity Participating Site, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must have subfoveal classic, predominantly classic, or minimally classic lesions, secondary to AMD.
  • Patients must have ETDRS best corrected visual acuity of 64 to 24 letters (20/50 to 20/320 Snellen Equivalent) in the study eye.
  • Patients must be age 50 or older

Exclusion criteria

  • Patients who have received prior treatment with any investigational new drug or device for wet AMD in the study eye within 24 weeks of the screening visit.
  • Patients with advanced glaucoma (greater than 0.8 cup:disk) or intraocular pressure above 22 mmHg in the study eye.
  • Patients with any retinal vasculopathies, including diabetic retinopathy, retinal vein occlusions, etc. in the study eye.
  • Patients with any subfoveal scarring, atrophy, or hemorrhage in the study eye.
  • Patients whose CNV lesion in the study eye contains more than 25% scarring and/or atrophy.
  • Patients who have undergone any extrafoveal/juxtafoveal laser treatment of the study eye within two weeks prior to the screening visit.
  • Patients who received treatment with an investigational drug within 4 weeks prior to the screening visit.

Treatment and study plan

Bevasiranib

Drug

Other names: Cand5

Primary outcomes

  1. change from baseline at the 12-week evaluation in macular edema as measured by optical coherence tomography.

    Time frame: 12 week

Secondary outcomes

  1. The secondary endpoint is the mean BCVA line/letters change from baseline at the 12-week evaluation.

    Time frame: 12 week

Sponsors and collaborators

Lead sponsor

OPKO Health, Inc.

Industry

Registry information

Official study title

A Phase II, Randomized, Double-Masked, Controlled, Dose Comparison Study of Cand5 for Intravitreal Injection for the Treatment of Subfoveal Choroidal Neovascularization Associated With Wet Age-Related Macular Degeneration

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Dec 1, 2005
Registry last updated
Aug 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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